Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

This study has been completed.

Sponsor:

Fred Hutchinson Cancer Research Center

ClinicalTrials.gov Identifier:

NCT01377168

First Posted: June 21, 2011

Last Update Posted: June 16, 2017

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This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either oral naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of oral naltrexone on alcohol use behaviors in this population.

The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.

Secondary Outcome Measures:

ART Compliance and Alcohol Use Behavior [ Time Frame: 6 months ]

Secondary HIV outcomes will include time to ART initiation, retention on ART over 6 months, and HIV sexual risk behaviors. Alcohol use outcomes include the following: 1) Time to relapse to heavy drinking (for men defined as >5 drinks/drinking day); 2) percent of days drinking (PDD) over the six-month examination period; 3) percent of days abstinent (PDA) over the six month examination period; and 4) alcohol craving using the Obsessive Compulsive Drinking Scale where a mean change in total score will be assessed and compared between treatment groups.

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